Phase 2
Completed N=60
Velcade, Trisenox, Vitamin C and Melphalan for Myeloma Patients
Source: ClinicalTrials.gov NCT00469209 ↗Enrolled (actual)
60
Serious AEs
11.7%
Results posted
Apr 2011
Primary outcomePrimary: Number of Patients Reaching Complete Response (CR) — 4; 1; 4 participants
Summary
Primary Objectives:
1. To evaluate the toxicity and safety of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
2. To evaluate the efficacy of a combination of bortezomib with arsenic trioxide, ascorbic acid and high-dose melphalan in patients with multiple myeloma
3. To determine the effects of bortezomib on melphalan pharmacokinetics
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Reaching Complete Response (CR) |
4; 1; 4 | — |
| SECONDARY Time to Toxicity |
— | — |
Eligibility Criteria
Inclusion Criteria
- a) Primary Refractory Disease (defined as failure to achieve even a partial response to induction therapy) b) Consolidation of a partial remission (defined as a decrease but continued presence of monoclonal protein on serum and urine immunofixation electrophoresis, and/or the presence of plasmacytosis on bone marrow aspirate and biopsy) c) Relapsing after prior therapy (disease relapsing after achieving a partial or complete response to prior conventional or high-dose therapy).
- Age up to 75 years.
- Zubrod performance status of 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.
- Forced expiratory volume (FEV1), forced volume vital capacity (FVC) and Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) >40%. No symptomatic pulmonary disease.
- Serum bilirubin 1L prior to drainage.
- HIV-negative.
- Negative Beta human chorionic gonadotrophin (hCG) test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
- Patient or guardian able to sign informed consent
- Corrected QT interval less than 470 msec.
Exclusion Criteria
- Corrected QT interval greater than 470 msec.
- Patients in complete remission (defined as the absence of monoclonal protein on serum and urine immunofixation electrophoresis, and the absence of plasmacytosis in bone marrow aspirate and biopsy).
- Patients with non-secretory myeloma.
Data sourced from ClinicalTrials.gov (NCT00469209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.